Unity™ Sleeveless Elevated Vacuum System

14/03/201

4

Form 8

Advantages of vacuum suspension V

acu

um

• Very firm suspension providing excellent

security and improved proprioception

• Elevated vacuum tends to assist in maintaining

more constant limb volume and thus

decreasing the need to add additional socks

• Elevated vacuum assists with wound healing

by improving circulation through the residual

limb

• Provides good distal comfort for bony or

sensitive distal ends as long as the socket is fit

properly (volume & length matching)

Challenges of vacuum suspension V

acu

um

• Conventional systems require use of sleeves

which restrict knee flexion and require

frequent repair and/or replacement

• Conventional pumps may increase weight

and bulk of the prosthesis

• Socket fit must be precise as ill fitting sockets

can cause tissue damage

• Suspension is compromised if seal fails

typically due to sleeve punctures or tears

• Potentially more maintenance with respect to

the vacuum pump mechanism

• Increased expense compared to basic

expulsion systems

Primary benefits of the Unity™ system U

nity™

⁺ SLEEVELESS: Increased knee flexion range with greater comfort and user acceptance

⁺ LIGHT WEIGHT AND DISCREET: 130g added weight and housed within foot shell

⁺ SIMPLE AND EFFICIENT: Quick and easy to elevate and release vacuum levels

⁺ INDEPENDENT PUMP: does not depend on shock mechanisms and can be added to a wide range of performance Flex-Foot systems to meet every mobility need.

⁺ VOLUME STABILISATION: Optimizes socket stability, proprioception and comfort throughout the day while limiting the need to add socks

⁺ INCREASED RELIABILITY: Minimizes risk of leaks and puncture issues associated with sleeve dependent vacuum methods

⁺ Integrates PERFORMANCE FLEX-FOOT technology to meet all activity requirements

Candidate Profiling U

se

r

• Indicated User Population:

– Transtibial amputees

– Low to high impact levels

– Weight limit is entirely based upon the recommended foot module

– Cylindrical shaped residual limbs with sufficient length to use Seal-In V are ideal for Unity

– Very conical limbs may be addressed with use of a Distal Cup

• Contraindications for use:

– Very short residual limbs that cannot use Seal-In V

– When total contact cannot be maintained distally between liner and limb

– When expecting significant volume changes

Building Blocks of the Unity™ system U

nity™

Seal-In® V

Unity™ TT Valve

Re-Flex® Shock

Re-Flex® Rotate

LP Rotate

Vari-Flex

LP Vari-Flex

Proprio

Unity™ Pump

1: Proven Seal-In Technology 2: Socket Connection

3: Performance Flex-Foot 4: Vacuum Pump Mechanism

Iceross Seal-In® V L

ine

r

Iceross Seal-In V

⁺ Dual sealing membrane enhances seal retention while volume adaptive blades accommodate volume changes

⁺ DermoGel Silicone – softest durometer available

⁺ Active Skin Care and Silken inner surface

⁺ Compatible with elevated vacuum AND expulsion-only sockets

⁺ Designed and tested in combination with Unity™

⁺ Available with low-profile and high-profile (+35mm higher) seals

Benefits over previous TT Seal-In's L

ine

r

Compared to HSM:

• 2nd seal increases security

• Less prone to fold or buckle

• Evenly fills in space between liner and socket with the Volume Adaptive Blades

• Better rotational control

Compared to X5:

• More forgiving fit with respect to shear force distributed to tissues around the seal

• In case of volume loss, socks can be tucked under seal to obtain up to 8 ply volume adaptation

• Superior seal retention with respect to tissue movement (i.e. muscular contractions inside the socket)

Product Sizing and Fitting L

ine

r

• Measure circumference 4cm from end of soft tissues.

• Select a liner as measured or next size below the indicated measurement

• Standard or High Profile Seal will depend on LIMB LENGTH (See Chart)

• On average the minimum residual limb length is 10-13cm(Std.) and 13-16cm(High Profile) depending on liner size

Measurement @ 4cm level = 28cm >> Select liner size 28

Measurement @ 4cm level = 24cm >> Select liner size 23.5

Product Sizing and Fitting L

ine

r

Seal-In V seal height is fixed at 5mm and

35mm from the start of the distal radius

Liner "cup" size varies, which affects

minimal residual limb length:

TT Unity™ tri-function valve D

efinitiv

e S

ocke

t

TT Unity™ valve D

efinitiv

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ocke

t

Unity™ TT Valve:

⁺ Tri-Function (Expulsion, Vacuum, Release)

⁺ No increased build height added to prosthesis

⁺ Built-in particulate filter

• Disassemble valve before trimming thread.

Metal shavings in duckbills and seals are no

fun!

• Valve thread needs to be sealed to the socket

(inner) wall. Use valve insert!.

• Good quality industrial grade silicone sealant

suits the job well

• Avoid lateral placement for protection

Integrated Unity™ Pump & Flex-Foot U

nity™

1. Frame & Support Blade:

Upon heel deflection, the frame moves up and

the support blade moves down, thus expanding

the membrane.

2. Check valves:

When air is efficiently drawn out of the socket,

check valves ensure that air does not flow back

into the socket (Pre-assembled for L side).

3. Heel pad:

The heel pad acts as a secure support for

Unity’s upper blade, and as a stop for heel

displacement at high load.

4. Membrane:

When the membrane expands, air is efficiently

drawn out of the socket.

Flex-Foot with Unity™ F

oot

Fitting a Flex-Foot with Unity is no different from

previous procedures:

• Select appropriate size and category

• Obtain good static alignment

• Remember to use wedges during

dynamic alignment

Unity Pump elevates vacuum up to -22inHg

Normal operating pressures are -16 to -20 inHg

Added weight is 130g (Pump, valve, tubing)

Running the vacuum tube medially is recommended to

prevent impact with foreign objects

Vacuum/exhaust ports on the Unity™ Pump are

exchangeable Right/Left. Default shipping setup is ideal for

a left foot.

Flex-Foot compatible with Unity™

Proprio Foot, LP Vari-Flex, Vari-Flex, LP Rotate, & Re-Flex Series

Casting Method T

est S

ocke

t

Cast:

• Measure: Circumferences & ML

• Neutral cast (Elastic + Rigid)

• Proximal >> Distal wrap

• 3-5° knee flexion

• Avoid tightening the cast and any distortion to limb shape

• Casting under vacuum is NOT required

Modification:

• Correct ML dimension

• Level out seal area on positive

• Global 3-5% volume reduction (from patient measurements)

• Remove 6mm distally

• Remember to attach valve insert when pulling the check socket

Note: Unity™ should not be used as a

remedy for already wide sockets or to

counteract discomfort in existing

sockets. Cavities and too wide sockets

can cause pain and/or serious injury

Evaluating the check socket T

est S

ocke

t

Ideal fit places the seal as high as possible on the limb (HP Seal shown

here) with equal distribution of pressure around the seal. Seal should

fully seat at least 1-2cm below the posterior socket trim lines.

Evaluating the check socket T

est S

ocke

t

Pressure against the V-seal can be "read" in a check socket:

Normal pressure.

Volume adaptive Blades

flatten the seal against the

socket wall (up to ~50%

compressed when de-

weighted, up to 100%

upon full weight bearing)

Low pressure area and

increased risk of suction

loss. Blades are barely

pushing the seal to the

socket wall.

Evaluating the check socket T

est S

ocke

t

BWS Three stage fitting process:

• Better

• Worse

• Same

1: Add one silicone spot to the bottom of the socket

2: Ask if it feels better, worse or the same: o Better - you had a void distally, add another spot

o Worse – your distal volume was correct, remove the last spot

o Same - you had a void distally, add another spot

3: Repeat until you have gone from W to B

Distal Volume Check

Evaluating the check socket T

est S

ocke

t

BWS Three stage fitting process:

• Better

• Worse

• Same

1: Add one sock, 1 ply, disregard the fact that the seal will not seal

2: Ask if it feels better, worse or the same: o Better - your socket was too big, add another sock

o Worse – your volume was correct, remove the last sock

o Same - your socket was too big, add another sock

3: Repeat until you have gone from W to B

Circumferential Volume Check

Correct for volume and length differences on the positive model

and fabricate another check socket if necessary.

Definitive socket structure and materials D

efinitiv

e S

ocke

t

ALWAYS use a PETG layer over the positive (WITH the valve insert attached to the positive model).

Use a conventional laminate overlay.

NEVER create an elevated vacuum socket without first using a plastic inner layer as laminate always leaks!

Identification of socket leaks T

roub

lesh

ooting

When using the recommended PETG to seal a socket interface, there are 3 potential places which may leak:

• Across the seal, especially when walking. Observe test socket well to prevent this from being discovered in the definitive socket.

• Through the seal; a damaged seal can leak, again it can be partly hidden since damaged seal can hold pressure statically.

• Across valve seat. Remember that valve thread needs to be sealed to the PETG inner surface. Use silicone sealant.

Warranty and maintenance

• Standard Flex-Foot warranty applies to foot module

• Unity Pump Kit – 24 Months

• Unity Membrane – 12 Months

• Seal-In V – 6 Months

• Unity is field serviceable. The entire system can be

disassembled, cleaned and individual components

replaced as needed.

• Maintenance kits (UVL00021, UVL00022) are

available which include membrane, check valves,

barb fittings, tubing, tube fastener and heel pad.

Customer Service and Clinical Support

• There is no training certification requirement to fit the

Unity system.

• Unity training and fitting support can be held at your

facility by request.

• Order Forms (online and fax version) are currently

available to make ordering the Unity system simpler

and easier.

• Full brochure on Unity to be released in March.

• Complete listing of all Unity system components in

2014 catalogue to be released in March.

Unity™ Sleeveless Elevated Vacuum System

14/03/201

4

Form 8